A randomised controlled trial of the efficacy of a carrageenan nasal spray when taken during a cold in reducing asthma exacerbations as measured by the asthma control questionnaire.
A randomised placebo controlled trial of the efficacy of carrageenan nasal spray in reducing asthma exacerbations, as measured by the asthma control questionnaire, when taken during a cold.
Julian Crane
360 participants
May 10, 2016
Interventional
Conditions
Summary
New Zealand has high rates of asthma and hospitalisations for asthma. Viral respiratory infections are the most common cause of asthma exacerbations in both children and adults. Preliminary laboratory and clinical evidence points to carrageenan nasal spray (an extract of red seaweed) being a potentially exciting new treatment for cold virus infections. This study will investigate how effective using a nasal spray containing carrageenan is as a treatment against the development of asthma exacerbations caused by cold infections, in adults with asthma.
Eligibility
Inclusion Criteria1
- People who have ever been doctor diagnosed with asthma, and who have had at least one cold in the past 12 months with asthma symptoms.
Exclusion Criteria1
- Those with COPD (doctor diagnosed), those who plan to use a nasal spray for another condition during the study period, those whose asthma does not worsen with a cold, those who have a previous sensitivity or allergy to carrageenan or other seaweed products, a history of nasal polyps, or those with 'current unstable asthma' which we define as having been hospitalised for asthma within the last 2 months or use of oral corticosteroids in the past month.
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Interventions
A nasal spray containing saline solution and 1.6 mg/ml carrageenan will be taken by participants in the active group during a cold. Each spray contains 0.14ml of the solution.. Participants will spray each nostril 4 times per day (first thing in the morning, at lunch time, at dinner time and before bed) for 10 days at the start of cold symptoms. Participants will fill in an asthma control questionnaire (ACQ) at baseline with no cold, and on day 7 and day 14 of a cold. From the start of a cold, cold symptoms and peak flow will be recorded daily for 14 days, and for a further 7 days if cold symptoms persist. Nasal swabs will be taken to establish virus type and viral positive colds on day 2 and day 10, and a further swab will be taken on day 18 if cold symptoms persist. Participants will be followed for 16 weeks between April and November (peak cold season), and will treat up to two colds using the spray during this time, if they experience cold symptoms. Nasal spray bottle weights will be measured to determine compliance. Participants will be skin prick tested to common environmental allergens (house dust mite, cat, mixed grasses) to establish their atopic status.
Locations(1)
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ACTRN12615001166561